| Primary | Change in the Sensory Neuropathic Pain Score as Measured by the European Organization of Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Chemotherapy-Induced Peripheral Neuropathy (CIPN) 20 Item (20) | Will estimate means and standard deviations by group for the EORTC QLQ-CIPN20 sensory subscale, the correlation between the two measures, and the within-person change. To estimate effect size, we will use an analysis of covariance (ANCOVA) model at week 12, which will include the group and the baseline value. Using a 4-point Likert scale (1 = "not at all," 2 = "a little," 3 = "quite a bit," and 4 = "very much"), individuals indicate the degree to which they have experienced sensory, motor, and autonomic symptoms during the past week. Sensory raw scale scores range from 1 to 36, motor raw scale scores range from 1 to 32, and autonomic raw scale scores range from 1 to 12 for men and 1-8 for women (erectile function item is excluded) [13]. All scale scores are linearly converted to a 0-100 scale, with higher scores indicating more symptom burden. | Number of participants analyzed may differ due to participants being lost to follow up or withdrawing from intervention. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline up to week 12 | | | | ID | Title | Description |
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| OG000 | Group 1 (Acupuncture) | Participants undergo 8 45-minute acupuncture treatments over 10 weeks. Acupuncture Therapy: Undergo acupuncture therapy Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies | | OG001 | Group 2 (Usual Care) | Participants receive usual care. Best Practice: Receive usual care Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies |
| | | Title | Denominators | Categories |
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| Baseline | - ParticipantsOG00010
- ParticipantsOG00112
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | ANCOVA | | 0.61 | | | | | | | | | | | | | | Other | | | | | | | | | Correlation Coefficient |
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| Secondary | Change in Motor and Autonomic Pain Subscores on the EORTC QLQ-CIPN20 | Means and standard deviations will be computed at baseline and week 12 by group, and for the change in the measures, and will also estimate the correlation between the measures at the two time points, and fit ANCOVA models for each outcome. Using a 4-point Likert scale (1 = "not at all," 2 = "a little," 3 = "quite a bit," and 4 = "very much"), individuals indicate the degree to which they have experienced sensory, motor, and autonomic symptoms during the past week. Sensory raw scale scores range from 1 to 36, motor raw scale scores range from 1 to 32, and autonomic raw scale scores range from 1 to 12 for men and 1-8 for women (erectile function item is excluded). All scale scores are linearly converted to a 0-100 scale, with higher scores indicating more symptom burden. | Number of participants analyzed may differ due to participants being lost to follow up or withdrawing from intervention. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline up to week 12 | | | | ID | Title | Description |
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| OG000 | Group 1 (Acupuncture) | Participants undergo 8 45-minute acupuncture treatments over 10 weeks. Acupuncture Therapy: Undergo acupuncture therapy Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies | | OG001 | Group 2 (Usual Care) | Participants receive usual care. Best Practice: Receive usual care Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies |
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| Secondary | Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling | Means and standard deviations will be computed at baseline and week 12 by group, and for the change in the measures, and will also estimate the correlation between the measures at the two time points, and fit ANCOVA models for each outcome. The CTCAE measure of CIPN will be assessed using frequencies of grade by time point (baseline, week 12), as well as whether the grade of CIPN increased, decreased or remained stable. A Fisher's Exact test will be used to compare the groups at each time point and for the change during the study period. | Number of participants analyzed may differ due to participants being lost to follow up or withdrawing from intervention. | Posted | | Count of Participants | | Participants | | Baseline up to week 12 | | | | ID | Title | Description |
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| OG000 | Group 1 (Acupuncture) | Participants undergo 8 45-minute acupuncture treatments over 10 weeks. Acupuncture Therapy: Undergo acupuncture therapy Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies | | OG001 | Group 2 (Usual Care) | Participants receive usual care. Best Practice: Receive usual care Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies |
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| Secondary | CIPN as Measured by National Cancer Institute (NCI)-CTCAE 5.0 Grades 1-3 Numbness or Tingling | The CTCAE measure of CIPN will be assessed using frequencies of grade by time point (baseline, week 12), as well as whether the grade of CIPN increased, decreased or remained stable. A Fisher's Exact test will be used to compare the groups at each time point and for the change during the study period. | Number of participants analyzed may differ due to participants being lost to follow up or withdrawing from intervention. | Posted | | Count of Participants | | Participants | | Up to week 12 | | | | ID | Title | Description |
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| OG000 | Group 1 (Acupuncture) | Participants undergo 8 45-minute acupuncture treatments over 10 weeks. Acupuncture Therapy: Undergo acupuncture therapy Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies | | OG001 | Group 2 (Usual Care) | Participants receive usual care. Best Practice: Receive usual care Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies |
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| Secondary | Number of Participants With Standard Chemotherapy Dose or Decreased Due to Peripheral Neuropathy | Means and standard deviations will be computed at baseline and week 12 by group, and will also estimate the correlation between the measures at the two time points | Number of participants analyzed may differ due to participants being lost to follow up or withdrawing from intervention. | Posted | | Count of Participants | | Participants | | Up to week 12 | | | | ID | Title | Description |
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| OG000 | Group 1 (Acupuncture) | Participants undergo 8 45-minute acupuncture treatments over 10 weeks. Acupuncture Therapy: Undergo acupuncture therapy Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies | | OG001 | Group 2 (Usual Care) | Participants receive usual care. Best Practice: Receive usual care Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies |
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| Secondary | Number of Cycles of Completed Chemotherapy | Means and standard deviations will be computed at baseline and week 12 by group, and will also estimate the correlation between the measures at the two time points, and fit ANCOVA models for each outcome. | Number of participants analyzed may differ due to participants being lost to follow up or withdrawing from intervention. | Posted | | Mean | Standard Deviation | cycles | | Up to week 12 | | | | ID | Title | Description |
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| OG000 | Group 1 (Acupuncture) | Participants undergo 8 45-minute acupuncture treatments over 10 weeks. Acupuncture Therapy: Undergo acupuncture therapy Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies | | OG001 | Group 2 (Usual Care) | Participants receive usual care. Best Practice: Receive usual care Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies |
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| Secondary | Cross Sectional Area (CSA) of Peripheral Nerves as Determined by Ultrasound (Sural and Median) | Means and standard deviations will be computed at baseline and week 12 by group, and will also estimate the correlation between the measures at the two time points, and fit ANCOVA models for each outcome. | Number of participants analyzed may differ due to participants being lost to follow up or withdrawing from intervention. Treatment ended early for 2 participants in the intervention group, discontinued the intervention | Posted | | Mean | Standard Deviation | meters squared | | Up to week 12 | | | | ID | Title | Description |
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| OG000 | Group 1 (Acupuncture) | Participants undergo 8 45-minute acupuncture treatments over 10 weeks. Acupuncture Therapy: Undergo acupuncture therapy Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies | | OG001 | Group 2 (Usual Care) | Participants receive usual care. Best Practice: Receive usual care Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies |
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| Secondary | Amplitude of Nerve Response Derived From Nerve Conduction Studies (NCS) (Sural, Tibial, and Median) | Means and standard deviations will be computed at baseline and week 12 by group, and will also estimate the correlation between the measures at the two time points, and fit ANCOVA models for each outcome. Nerve conduction studies measure impairment of electrical function in large peripheral nerves and measures amplitude and latency of neuronal signaling. Ranging from 0.1 μm to 20 μm. Reduction in the amplitude indicates axonal damage. | Number of participants analyzed may differ due to participants being lost to follow up or withdrawing from intervention. | Posted | | Mean | Standard Deviation | micrometers | | Up to week 12 | | | | ID | Title | Description |
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| OG000 | Group 1 (Acupuncture) | Participants undergo 8 45-minute acupuncture treatments over 10 weeks. Acupuncture Therapy: Undergo acupuncture therapy Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies | | OG001 | Group 2 (Usual Care) | Participants receive usual care. Best Practice: Receive usual care Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies |
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| Secondary | Distal Latency of Nerve Response Derived From NCS (Sural, Tibial, and Median) | Means and standard deviations will be computed at baseline and week 12 by group, and will also estimate the correlation between the measures at the two time points, and fit ANCOVA models for each outcome. | Number of participants analyzed may differ due to participants being lost to follow up or withdrawing from intervention. | Posted | | Mean | Standard Deviation | milliseconds | | Up to week 12 | | | | ID | Title | Description |
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| OG000 | Group 1 (Acupuncture) | Participants undergo 8 45-minute acupuncture treatments over 10 weeks. Acupuncture Therapy: Undergo acupuncture therapy Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies | | OG001 | Group 2 (Usual Care) | Participants receive usual care. Best Practice: Receive usual care Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies |
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| Secondary | Conduction Velocity of Nerve Response Derived From NCS (Sural, Tibial, and Median) | Means and standard deviations will be computed at baseline and week 12 by group, and will also estimate the correlation between the measures at the two time points, and fit ANCOVA models for each outcome. | Number of participants analyzed may differ due to participants being lost to follow up or withdrawing from intervention. Two participants in the intervention group discontinued the intervention/treatment earlier than the anticipated 12 weeks time frame. | Posted | | Mean | Standard Deviation | meters per second | | Up to week 12 | | | | ID | Title | Description |
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| OG000 | Group 1 (Acupuncture) | Participants undergo 8 45-minute acupuncture treatments over 10 weeks. Acupuncture Therapy: Undergo acupuncture therapy Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies | | OG001 | Group 2 (Usual Care) | Participants receive usual care. Best Practice: Receive usual care Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies |
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| Secondary | Nerve Fiber Density in the Skin | Means and standard deviations will be computed at baseline and week 12 by group, and will also estimate the correlation between the measures at the two time points, and fit ANCOVA models for each outcome. | Number of participants analyzed may differ due to participants being lost to follow up or withdrawing from intervention. | Posted | | Mean | Standard Deviation | fibers per millimeter | | Up to week 12 | | | | ID | Title | Description |
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| OG000 | Group 1 (Acupuncture) | Participants undergo 8 45-minute acupuncture treatments over 10 weeks. Acupuncture Therapy: Undergo acupuncture therapy Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies | | OG001 | Group 2 (Usual Care) | Participants receive usual care. Best Practice: Receive usual care Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies |
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